泰索帝版说明书
泰索帝版说明书

核准日期:2006年11月修改日期:2008年1月2009年3月多西他赛注射液说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:多西他赛注射液商品名称:泰索帝® TAXOTERE®英文名称:DOCETAXEL INJECTION汉语拼音:DUO XI TA SAI ZHUSHEYE【成份】化学名称: (2R,3S)-N-羧基-3-苯基异丝氨酸,N-叔丁基酯,13-酯链上5β-20-环氧-1,2α, 4,7β,10β, 13α-六羟紫杉醇-11-烯-9-酮4-乙酸2-苯甲酸酯三水合物泰索帝®:20mg –每支:20mg注射液为将相当于20mg 多西他赛(无水)的多西他赛三羟化合物,溶解于吐温80中而制成。
泰索帝®:80mg –每支:80mg注射液为将相当于80mg 多西他赛(无水)的多西他赛三羟化合物,溶解于吐温80中而制成。
每毫升泰索帝®注射液含有40 mg无水多西他赛。
泰索帝®溶剂-浓度为13% w/w 的注射用乙醇(以95%计)水溶液。
化学结构式:•3H2O分子式:C43H53NO14•3H2O分子量:本注射剂的全部辅料为:浓溶液:吐温80和氮气;溶剂:95%乙醇和注射用水。
【性状】黄至棕黄色的粘稠液体,配有溶剂。
几乎不溶于水,高脂溶性。
【适应症】多西他赛的适应症如下:乳腺癌1. 适用于局部晚期或转移性乳腺癌的治疗。
2. 泰索帝(多西他赛)联合曲妥珠单抗,用于HER2基因过度表达的转移性乳腺癌患者的治疗,此类患者先期未接受过转移性癌症的化疗。
3. 泰索帝(多西他赛)联合阿霉素及环磷酰胺用于淋巴结阳性的乳腺癌患者的术后辅助化疗。
非小细胞肺癌适用于局部晚期或转移性非小细胞肺癌的治疗,即使是在以顺铂为主的化疗失败后。
【规格】(1):20mg;(2):80mg【用法用量】多西他赛只能用于静脉滴注。
推荐剂量:一般性多西他赛的推荐剂量为每三周75mg/m2滴注一小时。
安维汀-抗血管生成治疗

VEGF单抗安维汀®通过多种机制提高化疗疗效
现有肿瘤血管系统1–3
退化
新生血管生长1–3, 8
抑制
现存血管系统11–13
抗通透性
持续提高缓解率4–7 持续控制肿瘤生长8–10 减少胸水和渗出液2, 3, 11, 14–20
1. Hurwitz H, et al. N Engl J Med 2004; 350: 2335-2342. 2. Jain RK. Nat Med 2001; 7(9): 987-990. 3. Margolin K. Curr Oncol Rep 2002; 4: 20-28. 4. Hu L, et al. Am J Pathol 2002; 161(5): 1917-1924. 5. Kaya A, et al. Respir Med 2004; 98: 632-636. 6. Des Guetz G, et al. Br J Cancer 2006; 94: 1823-1832. 7. O'Byrne KJ, et al. Br J Cancer 2000; 82(8): 1427-1432. 8. Yuan A, et al. Int J Cancer (Pred Oncol) 2000; 89: 475-483. 9. Escudier B, et al. Lancet 2007; 370: 2103-2111. 10. Dickson PV, et al. Clin Cancer Res 2007; 13: 3942-3950. 11. Sandler A, et al. N Engl J Med 2006; 355: 2542-2550. 12. Miller K, et al. N Engl J Med 2007; 357: 2666-2676. 13. Gerber HP, Ferrara N. Cancer Res 2005; 65: 671-680. 14. Mabuchi S, et al. Clin Cancer Res 2008; 14: 7781-7789. 15. Wild R, et al. Int J Cancer 2004; 110: 343-351. 16. Mesiano S, et al. Am J Pathol 1998; 153(4): 1249-1256. 17. Willett CG, et al. Nat Med 2004; 10(2): 145-147. 18. O’Connor JPB, et al. Clin Cancer Res 2009; 15: 6674-6682. 19. Prager GW, et al. Mol Oncol 2010; 4: 150-160. 20. Ribeiro SCC, et al. Respirology 2009; 14: 1188-1193. 21. Watanabe M, et al. Hum Gene Ther 2009; 20: 598-610. 22. Bellati F, et al. Invest New Drugs 2010; 28: 887-894. 23. Huynh H, et al. J Hepatol 2008; 49: 52-60. 24. Ninomiya S, et al. J Surg Res 2009; 154: 196-202. 25. Bergers G, Benjamin LE. Nat Rev Cancer 2003; 3: 401-410. 26. Kim KJ, et al. Nature 1993; 362(6423): 841-844. 27. Folkman. In: DeVita, Hellman, Rosenberg, eds. Cancer: Principles & Practice of Oncology. Vol 2. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005. 28. Ferrara N, et al. Nat Med 2003; 9(6): 669-676. 29. Inoue M, et al. Cancer Cell 2002; 1: 193-202. 30. Melnyk O, et al. J Urol 1999; 161: 960-963.
TE Connectivity Kissling Series 35 200A 电池断开开关说明书

KISSLINGBATTERY DISCONNECTORSeries 35 / 200A - from TE Connectivity (TE)Our manually operated battery disconnector up to 200 amps meets the most demanding requirements in all vehicle applications. The nom-inal current ratings refer to continuous DC current at up to 100% duty cycle and the switches are built to switch under full load. Our battery disconnector can handle up to five times the continuous current level for up to 10 seconds as overload current. (Overload current of 1000 amps for 30 seconds)All series 35 battery disconnectors are sealed with a technology that meets the IP67 and IP6K9K (steam preassure cleaning) standards and the switches are designed to operate at temperatures between -40°C and +85°C.Options include single or dual pole configurations, various mounting and locking (security) alternatives as well as different shapes and colors of the operating handles to serve your requirements.Battery disconnectors from our KISSLING product family are able to be operated under fall load, to ensure a safe disconnection from the battery in emergency conditions. The range also has optional protec-tion against theft or unauthorized use of vehicles or equipment by re-movable or lockable operating elements.Features• Sealed housing conforms to IP6K9K • Robust design• 6G shock and 4G vibration resistant • Main contact current rated for continu-ous current and 100% duty cycle • Battery disconnection under load in case of an emergency• Variable or scalable mounting options • Safety in the vehicle service by so called “LOCK” options (only two pole)Applications • Truck • Bus• Ground support vehicles• Construction and agricultural vehicles • Railway •AircraftSpecificationTechnical Data Temperature range -40°C to +85°C Protection IP67 / IEC 529Vibration 4g (50-2000 HZ)Shock6g, 11 msecThread sizes / Torque M8 = 12 - 13Nm | M10 = 15 - 20NmElectrical DataMin. insulation resistance 100M ΩDielectric withstanding voltage 1050V / 1 min at 50Hz Max. contact drop max. load 150 mVVoltage rangeup to 32VDC (optional up to 80VDC)Duty rating continuous 200A @ 70mm 2 / 300A @ 95mm 2Overload 500A - 180sec / 1000A - 30sec Wire section min 70mm 2 / min 95mm 2Mounting position optionalAvailable KeysKeyholderNot for switches with central mounting / optional available for 2-pole version1345Technical drawingsCircuitCircuitCircuitCircuit1-pole standard mounitng1-pole with longflange1-pole with central mounting2-poles with longflangeTE Connectivity, TE, TE connectivity (logo) and KISSLING (word) are trademarks owned or licensed by the TE Connectivity family of companies. All other logos, products and/or company names referred to herein might be trademarks of their respective owners.The information given herein, including drawings, illustrations and schematics which are intended for illustration purposes only, is believed to be reliable. However, TE Connectivity makes no warranties as to its accuracy or completeness and disclaims any liability in connection with its use. TE Connectivity‘s obligations shall only be as set forth in TE Connectivity‘s Standard Terms and Conditions of Sale for this product and in no case will TE Connectivity be liable for any incidental, indirect or consequential damages arising out of the sale, resale, use or misuse of the product. Users of TE Connectivity products should make their own evaluation to determine the suitability of each such product for the specific application.© 2020 TE Connectivity | All Rights Reserved. K1166706 | Version 08/2020Ordering InformationMounting option 1,3 and 4 also available for 1-pole version。
Anritsu Sitemaster S332D 使用说明

移动产品事业部售后文档文档名称:AnritsuSitemaster_S332D使用说明资料版本:V2006-R1.0产品版本:共20页(包括封面)拟制王延金审核标准化批准中兴通讯股份有限公司修改记录声明本资料著作权属中兴通讯股份有限公司所有。
未经著作权人书面许可,任何单位或个人不得以任何方式摘录、复制或翻译。
侵权必究。
和是中兴通讯股份有限公司的注册商标。
中兴通讯产品的名称和标志是中兴通讯的专有标志或注册商标。
在本手册中提及的其他产品或公司的名称可能是其各自所有者的商标或商名。
在未经中兴通讯或第三方商标或商名所有者事先书面同意的情况下,本手册不以任何方式授予阅读者任何使用本手册上出现的任何标记的许可或权利。
本产品符合关于环境保护和人身安全方面的设计要求,产品的存放、使用和弃置应遵照产品手册、相关合同或相关国法律、法规的要求进行。
由于产品和技术的不断更新、完善,本资料中的内容可能与实际产品不完全相符,敬请谅解。
如需查询产品的更新情况,请联系当地办事处。
前言AnritsuSitemaster_S332D是GSM-BSS重要的工具之一,本文讲述了该仪器仪表的功能、安装及使用方法。
目录第1章仪表使用指导说明 (1)1.1 仪表功能介绍 (1)1.1.1 仪表功能 (1)1.1.2 相关概念 (1)1.2 适用范围 (1)1.3 工作条件 (1)1.4 测试环境与版本 (2)1.4.1 硬件配置 (2)1.4.2 软件配置 (3)1.5 测试框图和测试流程图 (3)1.5.1 Site Master图示 (3)1.5.2 测试框图 (3)1.5.3 测试流程图 (4)1.6 测试步骤 (6)1.6.1 开机步骤 (6)1.6.2 校准 (6)1.6.3 进行线路扫描测量 (6)1.6.4 关机步骤 (11)1.6.5 测试记录表 (11)1.7 测试注意事项 (12)第1章仪表使用指导说明1.1 仪表功能介绍1.1.1 仪表功能日本Anritsu公司的Site Master B332D具有以下功能:●天线驻波比测试●部分仪表具有频谱仪功能1.1.2 相关概念1.2 适用范围●按频率测试驻波比、回波损耗●按距离测试驻波比、回波损耗1.3 工作条件⏹频率范围: 25 MHz ~ 4000MHz⏹频率精度: ≤± 75 ppm @ +25°C⏹频率分辨率: 100 kHz⏹输出功率: < 0 dBm (-10 dBm 标称值)⏹回波损耗: 范围: 0.00 ~ 60.00 dB⏹驻波比:范围:1.00 ~ 65.00⏹传输线损耗范围: 0.00 ~ 30.00 dB⏹测量精度: >42 dB 校准后⏹DTF(故障定位):垂直范围:回波损耗: 0.00 ~ 60.00 dB驻波比: 1.00 ~ 65.00水平范围:0 -(数据点-1) X 分辨率到最大1197 m(3929 ft);数据点= 130, 259, 517⏹水平分辨率(矩形窗口内):分辨率(meter) =(1.5 x 10^8) x (Vp)/DFVp是馈线的相对传播速率DF 是终止频率-起始频率(Hz)⏹语言: 中,英,法,德,日,西班牙⏹内部曲线存储: 可达200条曲线⏹设置配置: S332D - 20, S331D - 25⏹输入和输出端口:RF 输出: N型, 阴性, 50 Ohm最大输入烧毁功率: +23dBm,±50VDCRF 输入: N型, 阴性, 50 Ohm最大输入烧毁功率: +43dBm(峰值), ±50 VDC⏹外部频率参考输入(2 ~20 MHz):共用的BNC, 阴性50Ohm,( 5dBm ~ +10dBm)(只对S332D)⏹T1/E1 (接收和发射): Bantam 插座(只对S331D,选件50)⏹串行接口: RS-232 9针D-sub, 串行3线⏹安全:符合EN 61010-1 1级便携式设备标准⏹温度:工作温度: -10°C ~ +55°C⏹湿度: 85% 或更低⏹非工作温度: -51°C ~ +71°C⏹电源外部DC输入: +12.5 ~ +15伏直流最大1350 毫安内部: 镍氢电池: 10.8伏, 1800 mAH⏹外形: 尺寸(宽x 高x 深):25.4 厘米x 17.8厘米x 6.1 厘米(10.0英寸x 7.0 英寸x 2.4 英寸)⏹重量: <2.28 kg (<5 lbs)包括电池1.4 测试环境与版本1.4.1 硬件配置(测试需要的硬件,含线缆,仪表,接头,校准头)◆Site Master一台◆2米J头N型跳线电缆一根(备用)◆KK接头一个(备用)1.4.2 软件配置仅测试无需其它软件,如需要截图提交报告,可在Site Master保存目标图像后使用SiteMaster自带的分析软件导出所需图形至PC。
Eaton 265783 型号 NZM 电子制造电路保护器说明书

Eaton 265783Eaton Moeller series NZM - Molded Case Circuit Breaker. Circuit-breaker, 3p, 550A, N, 4General specificationsEaton Moeller series NZM molded case circuit breaker electronic2657834015082657833401 mm 207 mm 210 mm 18.24 kg RoHS conformIEC IEC/EN 60947Product NameCatalog NumberEANProduct Length/Depth Product Height Product Width Product Weight Compliances Certifications550 AIs the panel builder's responsibility. The specifications for the switchgear must be observed.15 kA26 kAMeets the product standard's requirements.Is the panel builder's responsibility. The specifications for the switchgear must be observed.Built-in device fixed built-in techniqueFixed550 ADoes not apply, since the entire switchgear needs to be evaluated.Min. 6 segments of 16 mm x 0.8 mm at flat conductor terminal 10 segments of 80 mm x 1 mm (2x) at rear-side width extension Max. 10 segments of 32 mm x 1 mm (2x) at flat conductor terminal10 segments of 50 mm x 1 mm (2x) at 1-hole module plate Max. 10 segments of 50 mm x 1 mm (2x) at rear-side connection (punched)Min. 5 segments of 25 mm x 1 mm at rear-side connection (punched)Rocker leverMeets the product standard's requirements.eaton-circuit-breaker-nzm-mccb-characteristic-curve-055.epseaton-manual-motor-starters-starter-nzm-mccb-wiring-diagram.eps eaton-manual-motor-starters-starter-msc-r-reversing-starter-wiring-diagram.epseaton-circuit-breaker-nzm-mccb-dimensions-022.epseaton-circuit-breaker-switch-nzm-mccb-3d-drawing-003.epsMN4-ME550IL01210010ZDA-CS-nzm4_3pDA-CD-nzm4_3pDA-DC-03_N4Rated operational current for specified heat dissipation (In) 10.11 Short-circuit ratingRated short-circuit breaking capacity Ics (IEC/EN 60947) at 690 V, 50/60 HzRated short-circuit breaking capacity Icu (IEC/EN 60947) at 400/415 V, 50/60 Hz10.4 Clearances and creepage distances10.12 Electromagnetic compatibilityMounting MethodAmperage Rating10.2.5 LiftingTerminal capacity (copper strip)Handle type10.2.3.1 Verification of thermal stability of enclosuresAmbient storage temperature - min Characteristic curve Diagramas de cableadoDibujoseCAD model Instrucciones de instalación mCAD modelReportes de certificaciones40 °CFitted with:Thermal protectionProtection against direct contactFinger and back-of-hand proof to VDE 0106 part 100Terminal capacity (copper busbar)Min. 60 mm x 10 mm at rear-side width extensionMax. 50 mm x 10 mm (2x) direct at switch rear-side connection Min. 25 mm x 5 mm direct at switch rear-side connectionMin. 25 mm x 5 mm at rear-side 1-hole module plateMax. 80 mm x 10 mm (2x) at rear-side width extension50 mm x 10 mm (2x) at rear-side 2-hole module plateMax. 50 mm x 10 mm (2x) at rear-side 1-hole module plateM10 at rear-side screw connection10.8 Connections for external conductorsIs the panel builder's responsibility.Special featuresIEC/EN 60947-4-1, IEC/EN 60947-2 The circuit-breaker fulfills all requirements for AC-3 switching category. R.m.s. value measurement and “thermal memory” Adjustable time delay setting to overcome current peaks tr at 6 x Ir also infinity (without overload releases) All AC-3 rating data applies to direct switching by the circuit-breaker under normal operating conditions. If, for example, a contactor takes over AC-3 switching under normal operating conditions, the full rated uninterrupted current applies to the circuit-breaker, In = Iu. Maximum back-up fuse, if the expected short-circuit currents at the installation location exceed the switching capacity of the circuit breaker (Rated short-circuit breaking capacity Icn) Rated current = rated uninterrupted current: 550 AAmbient operating temperature - max70 °CClimatic proofingDamp heat, constant, to IEC 60068-2-78Damp heat, cyclic, to IEC 60068-2-30Terminal capacity (aluminum stranded conductor/cable)50 mm² - 240 mm² (4x) at 4-hole tunnel terminalTerminal capacity (copper stranded conductor/cable)50 mm² - 185 mm² (4x) direct at switch rear-side connection120 mm² - 185 mm² (1x) direct at switch rear-side connectionLifespan, electrical2000 operations at 400 V AC-32000 operations at 690 V AC-13000 operations at 400 V AC-11000 operations at 690 V AC-33000 operations at 415 V AC-12000 operations at 415 V AC-3Electrical connection type of main circuitScrew connectionShort-circuit total breaktime< 25 ms ( 415 V); < 35 ms (> 415 V)Rated impulse withstand voltage (Uimp) at main contacts8000 VRated short-circuit breaking capacity Ics (IEC/EN 60947) at 400/415 V, 50/60 Hz26 kA10.9.3 Impulse withstand voltageIs the panel builder's responsibility.Utilization categoryB (IEC/EN 60947-2)Number of polesThree-poleAmbient operating temperature - min-25 °C10.6 Incorporation of switching devices and componentsDoes not apply, since the entire switchgear needs to be evaluated.10.5 Protection against electric shockDoes not apply, since the entire switchgear needs to be evaluated.Terminal capacity (control cable)0.75 mm² - 2.5 mm² (1x)0.75 mm² - 1.5 mm² (2x)Equipment heat dissipation, current-dependent33.58 WInstantaneous current setting (Ii) - min550 A10.13 Mechanical functionThe device meets the requirements, provided the information in the instruction leaflet (IL) is observed.10.2.6 Mechanical impactDoes not apply, since the entire switchgear needs to beevaluated.10.9.4 Testing of enclosures made of insulating materialIs the panel builder's responsibility.Rated operational current544 A (400 V AC-3)550 A (690 V AC-3)Rated short-circuit breaking capacity Ics (IEC/EN 60947) at 230 V, 50/60 Hz37 kAApplicationUse in unearthed supply systems at 525 V10.3 Degree of protection of assembliesDoes not apply, since the entire switchgear needs to be evaluated.Rated short-circuit making capacity Icm at 240 V, 50/60 Hz105 kARated short-circuit breaking capacity Ics (IEC/EN 60947) at 440 V, 50/60 Hz26 kADegree of protection (IP), front sideIP40 (with insulating surround)IP66 (with door coupling rotary handle)Rated short-circuit making capacity Icm at 525 V, 50/60 Hz53 kARated short-circuit making capacity Icm at 690 V, 50/60 Hz40 kAInstantaneous current setting (Ii) - max7700 AOverload current setting (Ir) - min275 A10.2.3.2 Verification of resistance of insulating materials to normal heatMeets the product standard's requirements.10.2.3.3 Resist. of insul. mat. to abnormal heat/fire by internal elect. effectsMeets the product standard's requirements.Lifespan, mechanical10000 operationsOverload current setting (Ir) - max550 AVoltage rating690 V - 690 VTerminal capacity (copper solid conductor/cable)120 mm² - 300 mm² (1x) at rear-side 1-hole module plate300 mm² (4x) at rear-side width extension95 mm² - 240 mm² (6x) at rear-side width extension95 mm² - 185 mm² (2x) at rear-side 2-hole module plate35 mm² - 185 mm² (4x) at rear-side 2-hole module plate50 mm² - 240 mm² (4x) at 4-hole tunnel terminal95 mm² - 300 mm² (2x) at rear-side 1-hole module plateDegree of protection (terminations)IP00 (terminations, phase isolator and strip terminal)IP10 (tunnel terminal)10.9.2 Power-frequency electric strengthIs the panel builder's responsibility.Short-circuit release non-delayed setting - min1100 ADegree of protectionIP20 (basic degree of protection, in the operating controls area) IP20Overvoltage categoryIIIRated short-time withstand current (t = 1 s)19.2 kARated impulse withstand voltage (Uimp) at auxiliary contacts 6000 VTerminal capacity (aluminum solid conductor/cable)70 mm² - 185 mm² (2x) at rear-side 1-hole module plate240 mm² (2x) at rear-side width extension50 mm² (4x) at rear-side 2-hole module plate185 mm² - 240 mm² (1x) at rear-side 1-hole module plate70 mm² - 240 mm² (6x) at rear-side width extensionSwitch off techniqueElectronicRated short-time withstand current (t = 0.3 s)19.2 kAAmbient storage temperature - max70 °CRated short-circuit breaking capacity Ics (IEC/EN 60947) at 525 V, 50/60 Hz19 kAOptional terminalsConnection on rear. Strip terminal. Tunnel terminalRelease systemElectronic releasePollution degree310.7 Internal electrical circuits and connectionsIs the panel builder's responsibility.Rated operating power at AC-3, 230 V160 kW10.10 Temperature riseThe panel builder is responsible for the temperature rise calculation. Eaton will provide heat dissipation data for the devices.FunctionsMotor protectionPhase failure sensitiveShort-circuit release non-delayed setting - max7700 AStandard terminalsScrew terminalRated short-circuit making capacity Icm at 400/415 V, 50/60 Hz 105 kARated operating power at AC-3, 400 V315 kWTypeCircuit breaker10.2.2 Corrosion resistanceMeets the product standard's requirements.10.2.4 Resistance to ultra-violet (UV) radiationMeets the product standard's requirements.10.2.7 InscriptionsMeets the product standard's requirements.Rated short-circuit making capacity Icm at 440 V, 50/60 Hz74 kAIsolation500 V AC (between auxiliary contacts and main contacts)Eaton Corporation plc Eaton House30 Pembroke Road Dublin 4, Ireland © 2023 Eaton. Todos los derechos reservados. Eaton is a registered trademark.All other trademarks areproperty of their respectiveowners./socialmedia300 V AC (between the auxiliary contacts)60NZM4As required 15 g (half-sinusoidal shock 11 ms)1000 VNumber of operations per hour - max Circuit breaker frame type Direction of incoming supply Shock resistanceRated insulation voltage (Ui)。
EATON 磁区断路器两路和三路电缆接锁套具安装和卸载说明说明书

Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitContentsDescription PageGeneral information . . . . . . . . . . . . . . . . . . . . . . . .2Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Functional test of interlock assembly . . . . . . . . .10Instructions apply to:Magnum T series IZM and Magnum DS/SB2Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitEATON m WARNING(1) ONLY QUALIFIED ELECTRICAL PERSONNEL SHOULD BE PERMITTED TO WORK ON THE EQUIPMENT.(2) ALWAYS DE-ENERGIZE PRIMARY AND SECONDARY CIRCUITS IF A CIRCUIT BREAKER CANNOT BE REMOVED TO A SAFE WORK LOCATION.(3) DRAWOUT CIRCUIT BREAKERS SHOULD BE LEVERED (RACKED) OUT TO THE DISCONNECT POSITION.(4) ALL CIRCUIT BREAKERS SHOULD BE SWITCHED TO THE OFF POSITION AND MECHANISM SPRINGS DISCHARGED.FAILURE TO FOLLOW THESE WARNINGS FOR ALL PROCEDURESDESCRIBED IN THIS INSTRUCTION LEAFLET COULD RESULT IN DEATH, BODILY INJURY, OR PROPERTY DAMAGE.m WARNINGTHE INSTRUCTIONS CONTAINED IN THIS IL AND ON PRODUCT LABELS HAVE TO BE FOLLOWED. OBSERVE THE FIVE SAFETY RULES: – DISCONNECTING– ENSURE THAT DEVICES CANNOT BE ACCIDENTALLY RESTARTED – VERIFY ISOLATION FROM THE SUPPLY – EARTHING AND SHORT-CIRCUITING– COVERING OR PROVIDING BARRIERS TO ADJACENT LIVE PARTSDISCONNECT THE EQUIPMENT FROM THE SUPPLY. USE ONLY AUTHORIZED SPARE PARTS IN THE REPAIR OF THE EQUIPMENT. THE SPECIFIEDMAINTENANCE INTERVALS AS WELL AS THE INSTRUCTIONS FOR REPAIR AND EXCHANGE MUST BE STRICTLY ADHERED TO PREVENT INJURY TO PERSONNEL AND DAMAGE TO THE SWITCHBOARD.General informationThis information leaflet provides detailed installation instructions for installing and interconnecting one drawout Magnum T breaker to another type of low voltage circuit breaker (LVCB) in any position (see A, B, C in T able 1 and T able 2) for a two-way, three-way Type 31, or three-way Type 33 interlock configuration as shown in Figure 1 . When purchasing kits for a two-way or a three-way interlock configuration setup, additional interlock kits (the types of interlock kits and the other breakers on which they can be installed that are compatible with this kit are listed in T able 3 and T able 4) are required for the other breaker(s) as well as the interconnecting cable kits (one, two, or three are required depending on whether a two-way, three-way Type 31, or three-way Type 33 interlock configuration is desired, respectively) .For two-way and three-way interlock configurations, the mechanical interlock holds one or more of the breakers tripped or open(prevents closure) when some combination of the others are closed . A lever assembly is mounted on each breaker and interfaces with the pole shaft and trip lever . The lever assemblies areinterconnected with cables provided in interconnecting cable kits (listed in T able 5) that are compatible with this interlock kit . Thecable kits, purchased separately, each contain two cables and can be used for any orientation of the breakers according to the installation recommendations in Step 7 .Refer to Figure 2 and Figure 3 for identification of interlock kit and interconnecting cable kit contents, respectively .BC BC ABABCDC DTwo-way cable routingThree-way Type 31cable routingThree-way Type 33cable routingABC DABCDABC DFigure 1. Cable routing for two-way and three-way T ype 31 and T ype 33 interlock configurations T able 1. T wo-way interlock logicBreaker ABreaker BAllowed states or conditions 0010010 = open 1 = closed3Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitEATON T able 2. T wo-way T ype 31 and T ype 33 interlock logicType 33 (six cable)Type 31 (four cable)Breaker Breaker ABCABCAllowed states or conditions 000000100100010101001001———0100 = open 1 = closedT able 3. T wo-way interlock assembly kits for interconnected breakersInterconnected breakerInterlock assembly kit for fixed breakerInterlock assembly kit for drawout breakerNRX Type NF frame IZMX-MIL2C-F16-2IZMX-MIL2C-W16-2NRX Type RF frameIZMX-MIL2C-F40-2IZMX-MIL2C-W40-2Magnum DS T , SB or IZMMCI2W3W3133FX MCI2W3W3133DOT able 4. Three-way interlock assembly kits for interconnected breakersInterconnected breakerInterlock assembly kit for fixed breakerInterlock assembly kit for drawout breakerNRX Type NF frame IZMX-MIL3133C-F16-2IZMX-MIL3133C-W16-2NRX Type RF frame IZMX-MIL3133C-F40-2IZMX-MIL3133C-W40-2Magnum DS, SB or IZM MCI2W3W3133FX MCI2W3W3133DOT able 5. Interconnecting cable kits (two cables per kit) aCable kit lengthCatalogue number1,5 m (5 ft)IZMX-MIL-CAB1520-21,8 m (6 ft)IZMX-MIL-CAB1830-22,4 m (8 ft)IZMX-MIL-CAB2440-23,0 m (10 ft)IZMX-MIL-CAB3050-2a Cable kits are purchased separately as needed.(F)Grease tube3x(B)M6 x 25 mm flathead screw1x(G)Cable bracket1x(H)M6 x 10 mm thread-forming screws2x(E)Interlock assembly1x(D)Drive arm1x(C)Lock washer3x(A)M6 x 12 mm hex bolt 3x Figure 2. Interlock kit part identification, includes parts to install on a single drawout Magnum breaker and cassette (does not include cables)4Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitEATON Figure 3. Interconnecting cable kit part identification (includes cables)Installation of two-way cable interlockRequired tools• 10 mm hex socket • 10 mm open-end wrench • 11/16-inch open-end wrench • 3/8-inch open-end wrench (2)• 4 mm Allen wrench • Drive extension • Pliers • Ratchet•Measuring instrument, in mmBefore proceeding with the following steps, ensure that all breakers are in the OPEN and DISCHARGED position .Step 1Remove the four hex-head captive bolts (six for 4-pole breaker) holding the cover in place as shown in Figure 4 . Pull down on the charginghandle (approximately 45 degrees) and remove the front cover .Figure 4. Details for Step 1Step 2Remove drive arm window as shown in Figure 5 . Either use a utility knife to cut the window from the cover, or use a punch and a small hammer to carefully punch out the window . Once the window is removed, use a small file to remove any burrs that remain . Make certain that all pieces and/or particles are cleaned up and removed before proceeding .Figure 5. Details for Step 25Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitEATON Step 3Install the drive arm (D) to the end of the pole shaft using an M6 x 25 mm flat-head screw (B) . Apply Loctite T Blue 242 to ensure that the screw cannot loosen during operation . The drive arm should be oriented as shown in Figure 6 . Torque to 7,3–9,6 N∙m (65–85 in-lb) .Pole shaft(B)(D)End of pole shaftFigure 6. Details for Step 3 and 4Step 4Reinstall the front cover using the four hex-head captive bolts (six for 4-pole breaker) removed in Step 1 .Step 5Fasten the interlock assembly (E) to the drawout cassette’s right-side sheet using three M6 x 12 mm hex bolts (A) and three lock washers (C) as shown in Figure 7 . Torque to 4,5–5,6 N∙m (40–50 in-lb) .Cassette right-side sheet(E)(A)(C)Figure 7. Details for Step 5Step 6Fasten cable bracket (G) to the drawout cassette’s right-side sheetjust below the interlock assembly (mounted in Step 5) using two M6 x 10 mm thread-forming screws (H) as shown in Figure 8 . Torque to 7,3–9,6 N∙m (65–85 in-lb) . Ensure the trip paddle is behind (on the same side as the back of the breaker) the trip lever as shown in Figure 9 .(H)(G)Cassette right-side sheetFigure 8. Details for Step 6Trip paddleTrip leverFollower armDrive armFigure 9. Details for Step 66Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitEATON Step 7This step offers cable routing and installation procedures . Make sure that cables move freely in their cable housings before installation . When attaching cables to swivel fittings, ensure that both ends of the cable are connected to push swivel fittings or both ends of the cable are connected to pull swivel fittings (refer to Figure 11) . For example, a cable connected to the drive lever pull swivel fitting on Breaker A must connect to the driven level pull swivel fitting on Breaker B .ATTENTIONFIGURE 10 SHOWS THE TYPICAL CABLE ROUTING FOR TWO-WAY AND THREE-WAY TYPE 31 AND TYPE 33 INTERLOCK CONFIGURATIONS.NOTICE THAT DEPENDING ON THE POSITION OF THE BREAKER WITHIN THE INTERLOCK CONFIGURATION, THE CABLES WILL BE ATTACHED IN DIFFERENT LOCATIONS. THE CABLE MOUNTING ON BOTH SWIVEL FITTINGS OF THE DRIVE AND DRIVEN LEVERS ARE DESCRIBED BELOW. TABLE 6 SHOWS THE TWO-WAY INTERLOCK LOGIC DEPENDING ON POSITION. TABLE 7 SHOWS THE THREE-WAY TYPE 31 AND TYPE 33 INTERLOCK LOGIC DEPENDING ON POSITION.BC BC ABABC DCDTwo-way cable routingThree-way Type 31cable routingThree-way Type 33cable routingABCDABC DABCDFigure 10. Cable routing for interlock configurationsT able 6. T wo-way interlock logicBreaker ABreaker BAllowed states or conditions 0010010 = open 1 = closedT able 7. Three-way T ype 31 and T ype 33 interlock logicType 33 (six cable)Type 31 (four cable)Breaker Breaker ABCABCAllowed states or conditions 000000100100010101001001———0100 = open 1 = closed7Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitEATON Installation recommendations• 102 mm (4 in) minimum allowable cable housing bend radius •Use plastic wire ties / clamps to attach cable housing to structure after installation and adjustment • Do not compress cable housing •Recheck to ensure cables move freelyDriven lever pull swivel fittingDriven lever push swivel fittingDriven leverDrive lever pull swivel fittingDrive lever push swivel fitting GapDrive lever Figure 11. Push and pull swivel fitting identificationStep 8This step describes how to first attach the drive (short rod) end of a cable to its interlock assembly and cable bracket . See Figure 12 .To attach the drive (short) end of the cable to the drive lever pull swivel fitting (refer to Figure 11), follow the directions below .1. Remove the upper nut, compression spring, and 38,1 mm(1,5 in) tube spacer from end of rod of cable assembly .2. Slide rubber boot toward tip of rod .3. Unthread outer bulkhead nut, and slide nut and lock washertoward tip .4. Insert threaded end of rod into swivel fitting .5. Slide smaller diameter portion of bulkhead fitting into cablebracket slot .6. Raise the cable assembly until threaded portion of bulkheadfitting enters slotted hole in cable bracket (threads show above bracket) .7. Bring bulkhead washer and nut down to threads andhand tighten .8. Adjust two bulkhead nuts to approximately center the bulkheadfitting on the cable mounting bracket . 9. Hand tighten the bulkhead nuts at this time .10. Slide rubber boot back into place over end of bulkhead fitting .11. Replace 38,1 mm (1,5 in) tube spacer, compression spring, andupper nut on end of rod .12. Lower nuts should be shouldered against end of thread andupper nut tightened against tube spacer .13. Hold lower nuts and torque upper nut to 3,3–4,5 N∙m (30–40 in-lb) .To attach the drive (short rod) end of a cable to the drive leverpush swivel fitting of the drive lever (refer to Figure 11), follow the directions below (see Figure 12) .1. Remove upper nut from end of rod of cable assembly .2. Slide rubber boot toward tip of rod .3. Unthread outer bulkhead nut and slide nut and lock washertoward tip .4. Insert threaded end of rod with 38,1 mm (1,5 in) tube spacerinto swivel fitting, ensuring that the compression spring remains between the lower nuts and the swivel .5. Slide smaller diameter portion of bulkhead fitting into cablebracket slot .6. Raise the cable assembly until threaded portion of bulkheadfitting enters slotted hole in cable bracket (threads show above bracket) .7. Bring bulkhead washer and nut down to threads andhand tighten .8. Adjust two bulkhead nuts to approximately center the bulkheadfitting on the cable mounting bracket . 9. Hand tighten the bulkhead nuts at this time .10. Slide rubber boot back into place over end of bulkhead fitting .11. Lower nuts should be shouldered against end of thread andupper nut tightened against tube spacer .12. Hold lower nuts and torque upper nut to 3,3–4,5 N∙m(30–40 in-lb) .8Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitEATON Figure 12. Details for Step 8: Cable assembly drive (short rod) end mounting component identification, mounting cable assembly in cable bracket, and cable rod attachment to drive arm9Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitEATON Step 9This step describes how to attach the driven (long rod) end of a cable attached to an interlock assembly on another breaker to the cable bracket and interlock assembly on this Magnum breaker . Refer to Figure 10 and Figure 11 for cable routing and correct swivel fittings to which the cables are connected .The driven (long rod) end of the cable is attached to the correspond-ing push or pull swivel fitting on the driven lever on this cable interlock assembly similarly to Step 8 except the driven end does not utilize a compression spring between the swivel and nut .Remove and discard the 22,2 mm (0,875 in) cable tube spacer (K) on the rod end of the cable assembly (I) and replace it with the 38,1 mm (1,5 in) cable tube spacer (J) . Install the cable as shown in Figure 13 and Figure 14 .Upper nuts Swivel fittings 38,1 mm (1,5 in) cable tube spacer Driven end (long end)Lower nuts Rubber bootDriven end cable bracketsOuter bulkhead nutBulkhead nutFigure 13. Details for Step 9Step 10This step describes how to adjust the cables to ensure proper functionality of the cable interlock setup . Cable adjustments are made with the large bulkhead nuts ONL Y and with all breakers OPEN . Nuts on the rod ends should not be moved .Begin by adjusting or verifying that all bulkhead fittings areapproximately centered on the cable mounting brackets (center of threaded section of bulkhead), allowing for room for adjustment in either direction . Hand tighten the nuts at this time .Perform initial adjustments on the driven (long rod) end of cable . There should be a small (0–5 mm) clearance between the upper nut and the face of the driven lever pull swivel on which it pulls and between the lower nuts and the face of the driven lever push swivel on which it pushes as shown in Figure 14 .If there is too much clearance , adjust both bulkhead nuts to retract the cable housing (move threaded portion down) .If there is no clearance , advance the cable housing in the same manner (move threaded portion up) .If additional adjustment length is needed, the bulkhead nuts on the other end of cable can be used .When the proper clearance is attained on the driven end, torque the cable bulkhead nuts on both ends to 11–13 N∙m (100–120 in-lb) without moving the bulkhead fittings .After the driven end has been adjusted and the bulkhead nuts have been tightened, perform adjustments on the drive (short rod) end of the cable . Adjust the bulkhead nuts up (move threaded portion down) such that the gap between the drive lever and the interlock assembly base shown on Figure 11 is less than 4 mm .When the gap is less than 4 mm, torque the cable bulkhead nuts on both ends to 11–13 N∙m (100–120 in-lb) .Between 0 and 5 mm after adjusting cableBetween 0 and 5 mm after adjusting cableTighten these nuts before mounting driven endAdjustment nutsAdjustment nuts Cable bracketLong rodDrive lever Short rod Drive endFigure 14. Details for Steps 9 and 1010Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitEATON Functional test of interlock assemblyBegin test sequence with all breakers OPEN .T wo-way interlock configuration functional testCheck 1: CHARGE and CLOSE Breaker A• Verify that Breaker A closed using the OPEN/CLOSED indication •Inspect the driven lever on Breaker B . Check that it rotated from its initial position•CHARGE and attempt to CLOSE Breaker B . It should not respond to CLOSE attempt (no noise, spring discharge, or contact motion)•If Breaker B responds to the CLOSE attempt, then additional adjustments may be required at the cable mounting brackets (refer to Steps 8, 9, and 10)Check 2: Open Breaker A• The interlock should release•CLOSE Breaker B (if already CHARGED) . Verify that it closes using the OPEN/CLOSED indication• Breaker A should remain in the OPEN position •OPEN Breaker BRepeat Checks 1 and 2 above on Breaker B , using Breaker B as Breaker A and Breaker A as Breaker B•Verify proper operation on both breakersThe mechanical interlock is now properly installed and adjusted for the two-way interlock configuration . Use a light amount of supplied lubricant (F) if any interlock parts are sticky or do not fully reset . This is only recommended if needed .T ype 31—Four-cable interlock assembly testRefer to T able 2 for logic details .• CHARGE and CLOSE Breaker A•CHARGE and attempt to CLOSE Breaker B . It should not respond to CLOSE attempt (no noise, spring discharge, or contact motion)•CHARGE and CLOSE Breaker C . Verify that Breaker C closes using the OPEN/CLOSED indication and that Breaker A remains CLOSED•CHARGE and attempt to CLOSE Breaker B again . It should still not respond to CLOSE attempt (no noise, spring discharge, or contact motion)•OPEN Breaker A . Verify that Breaker C is still CLOSED . CHARGE and attempt to CLOSE Breaker B . It should still not respond to CLOSE attempt (no noise, spring discharge, or contact motion)• OPEN Breaker C . All breakers should now be OPEN•CHARGE and CLOSE Breaker B . CHARGE and attempt to CLOSE Breakers A and C . Verify that they do not respond to CLOSE attempt (no noise, spring discharge, or contact motion)The mechanical interlock is now properly installed and adjusted for the three-way Type 31 interlock configuration . Use a light amount of supplied lubricant (F) if any interlock parts are sticky or do not fully reset . This is only recommended if needed .T ype 33—Six-cable interlock assembly testRefer to T able 2 for logic details .• CHARGE and CLOSE Breaker A•CHARGE and attempt to CLOSE Breakers B and C . Verify that neither breaker responds to CLOSE attempt (no noise, spring discharge, or contact motion)•OPEN Breaker A . The interlock should release•Repeat above test on Breakers B using B for A , C for B , and A for C and Breaker C using C for A , A for B , and B for CThe mechanical interlock is now properly installed and adjusted for the three-way Type 33 interlock configuration . Use a light amount of supplied lubricant (F) if any interlock parts are sticky or do not fully reset . This is only recommended if needed .Figure 15. Functional test gap checks11Instruction Leaflet IL0131082ENEffective April 2015Installation and removal instructions for Magnum drawout breaker two-way and three-way cable interlock kitEATON Eaton1000 Eaton Boulevard Cleveland, OH 44122 United StatesEaton .com© 2015 EatonAll Rights ReservedPrinted in USAPublication No . IL0131082EN / Z16558 Part Number: IL0131082ENH02April 2015Eaton is a registered trademark.All other trademarks are propertyof their respective owners. Installation and removal instructions for Magnum drawout breaker two-way andthree-way cable interlock kitInstruction Leaflet IL0131082ENEffective April 2015Disclaimer of warranties and limitationof liabilityThe information, recommendations, descriptions, and safety notations in this document are based on Eaton’s experience and judgment, and may not cover all contingencies . If further information is required, an Eaton sales office should be consulted .Sale of the product shown in this literature is subject to the terms and conditions outlined in appropriate Eaton selling policies or other contractual agreement between Eaton and the purchaser .THERE ARE NO UNDERSTANDINGS, AGREEMENTS, WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY, OTHER THAN THOSE SPECIFICALL Y SET OUT IN ANY EXISTING CONTRACT BETWEEN THE PARTIES . ANY SUCH CONTRACT STATES THE ENTIRE OBLIGATION OF EATON . THE CONTENTS OF THIS DOCUMENT SHALL NOT BECOME PART OF OR MODIFY ANY CONTRACT BETWEEN THE PARTIES .In no event will Eaton be responsible to the purchaser or user in contract, in tort (including negligence), strict liability or otherwisefor any special, indirect, incidental or consequential damage or loss whatsoever, including but not limited to damage or loss of use of equipment, plant or power system, cost of capital, loss of power, additional expenses in the use of existing power facilities, or claims against the purchaser or user by its customers resulting fromthe use of the information, recommendations and description contained herein .The information contained in this manual is subject to change without notice .。
紫杉类抗肿瘤药物特点及临床合理应用

在多西他赛用药后平均8天,中性粒细胞计数降到最低 点(400/mm3)
可对逆于及中性非粒蓄细胞积的性下降的,可以采取G-CSF预防性用药
很少并发感染及发热
非血液学不良反响
紫杉醇
多西他赛
过敏反响
过敏反响
心血管毒性
皮肤及皮下组织异常
紫杉类药物药理作用机制
星状体微管束
3’位与 β-tubulin N末端的1-31氨基酸残基结合 2位与β-tubulin 217-233氨基酸结合 7位与β-tubulin Arg282结合
He LF, Orr GA, Horwitz SB drug Discovery Today 2001 :1153
紫杉醇研发过程
年代
进
展
1958
NCI开始大规模植物药研发筛选
1967
发现紫杉醇抗癌活性
1968
从红豆杉中分离出紫杉醇
1971
完成结构鉴定
1979
发表作用机制
1983
临床Ⅰ试验
1985
临床II期
1991
临床III期
1992
FDA批准上市
national cancer institute 〔NCI〕〕
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、心动过缓等,但通
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5. 肌痛、关节痛胃肠道反 应,口腔皮肤质 体
1.骨髓抑制:严重粒缺达47%
2.外周神经毒:62%,严重 达6%
3.过敏反应:潮红、皮疹、 呼吸困难、低血压、心 动过速。曾发生过敏禁 用。
4.心血管毒:低血压、心动 过缓肌肉关节疼痛。, 呈剂量依赖型。
溶剂型紫杉醇促使循环中胶束的形成
参附注射液临床应用的文献梳理

参附注射液临床应用的文献梳理柏冬;刘丽梅;岳广欣;王瑞海【摘要】目前参附注射液在临床中广泛应用,本文拟对文献报道中参附注射液的临床适应症及其联合用药情况进行梳理.本文以"参附注射液"为检索词,检索中国期刊全文数据库涉及参附注射液的临床使用报道,共检索文献719篇,共涉及疾病104种,例如心力衰竭、肺源性心脏病、心肌梗死、休克、心律失常、冠心病等疾病.其中单独使用参附注射液治疗文献519篇,涉及疾病76种,联合其他药物治疗文献200篇,涉及疾病54种.希望通过本文为参附注射液的临床使用提供指导.【期刊名称】《环球中医药》【年(卷),期】2014(007)001【总页数】5页(P68-72)【关键词】参附注射液;临床应用;单独使用;联合用药【作者】柏冬;刘丽梅;岳广欣;王瑞海【作者单位】100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所【正文语种】中文【中图分类】R605.975参附注射液由红参、黑附片的提取物组成,该品种收载于卫生部药品标准中药成方制剂第十八册中,为内科用药,属于温里剂中的回阳救逆剂。
自1983年开始有临床报道以来[1],发表了大量关于参附注射液的临床使用文献,涉及疾病种类较多。
为了明确参附注射液的临床适应症及其使用方法,为其临床应用提供指导,本文采用文献学方法,对目前有关参附注射液临床使用的文献进行梳理。
1.1 资料来源以“参附注射液”为检索主题词,在中国学术期刊网络出版总库中检索自建国以来的全部文献,将文献信息导入医学文献王3.0中。
1.2 文献的纳入、分类及排除文献的纳入标准:所有涉及参附注射液临床使用报道的文献。
文献的排除标准:排除所有参附注射液动物药理实验文献、综述文献、临床医案文献、Meta分析类文献、临床病例数小于10例的文献、参附注射液非主要治疗药物、参附注射液为对照药物类文献。
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核准日期:2006年11月 修改日期:2008年1月 2009年3月多西他赛注射液说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:多西他赛注射液商品名称:泰索帝® TAXOTERE ® 英文名称:DOCETAXEL INJECTION 汉语拼音:DUO XI TA SAI ZHUSHEYE【成份】化学名称: (2R,3S)-N-羧基-3-苯基异丝氨酸,N-叔丁基酯,13-酯链上5β-20-环氧 -1,2α, 4,7β,10β, 13α-六羟紫杉醇-11-烯-9-酮4-乙酸2-苯甲酸酯三水合物泰索帝® 0.5ml:20mg –每支0.5ml:20mg 注射液为将相当于20mg 多西他赛(无水)的多西他赛三羟化合物,溶解于0.5ml 吐温80中而制成。
泰索帝® 2.0ml:80mg –每支2.0ml:80mg 注射液为将相当于80mg 多西他赛(无水)的多西他赛三羟化合物,溶解于2.0ml 吐温80中而制成。
每毫升泰索帝®注射液含有40 mg 无水多西他赛。
泰索帝®溶剂-浓度为13% w/w 的注射用乙醇(以95%计)水溶液。
化学结构式:•3H 2O分子式:C 43H 53NO 14•3H 2O 分子量:861.9本注射剂的全部辅料为:浓溶液:吐温80和氮气;溶剂:95%乙醇和注射用水。
【性状】黄至棕黄色的粘稠液体,配有溶剂。
几乎不溶于水,高脂溶性。
【适应症】多西他赛的适应症如下:乳腺癌1. 适用于局部晚期或转移性乳腺癌的治疗。
2.泰索帝(多西他赛)联合曲妥珠单抗,用于HER2基因过度表达的转移性乳腺癌患者的治疗,此类患者先期未接受过转移性癌症的化疗。
3. 泰索帝(多西他赛)联合阿霉素及环磷酰胺用于淋巴结阳性的乳腺癌患者的术后辅助化疗。
非小细胞肺癌适用于局部晚期或转移性非小细胞肺癌的治疗,即使是在以顺铂为主的化疗失败后。
【规格】(1)0.5ml:20mg;(2)2.0ml:80mg【用法用量】多西他赛只能用于静脉滴注。
推荐剂量:一般性多西他赛的推荐剂量为每三周75mg/m2滴注一小时。
为减轻体液潴留,除有禁忌外,所有病人在接受多西他赛治疗前均必须预服药物。
此类药物只能包括口服糖皮质激素类,如地塞米松,在多西他赛滴注一天前服用,每天16mg(例如:每日2次,每次8mg),持续3天。
只有医生才能修改治疗方案。
多西他赛不能用于中性粒细胞数目低于1500/mm3的病人。
多西他赛治疗期间,如果病人发生发热性中性粒细胞减少且中性粒细胞数目持续一周以上低于500/mm3,出现严重或蓄积性皮肤反应或外周神经症状,多西他赛的剂量应酌情递减。
乳腺癌在可以手术的淋巴结阳性的乳腺癌辅助化疗中,推荐剂量为:给予阿霉素50mg/m2及环磷酰胺500mg/m2一小时后,给予多西他赛75mg/m2,每三周一次,进行6个周期(见治疗中调整剂量)。
治疗局部晚期或转移性乳腺癌患者时,多西他赛单一用药的推荐剂量为100mg/m2。
一线用药时,多西他赛75mg/m2联合阿霉素(50mg/m2)(见安全处置建议)。
与曲妥珠单抗联合用药时,多西他赛推荐剂量为:100mg/m2,每三周一次,曲妥珠单抗每周一次。
在一项关键临床研究中,多西他赛首次静脉给药应于曲妥珠单抗第一次用药后一天。
如果患者对前次曲妥珠单抗剂量耐受良好,多西他赛以后的用药应紧随曲妥珠单抗静脉输注之后给药。
曲妥珠单抗的用法及用量,见其产品说明书。
非小细胞肺癌治疗非小细胞肺癌时,对于前期未经治疗的患者治疗非小细胞肺癌推荐剂量为多西他赛75mg/m2并立即给予顺铂75mg/m2静脉输注30-60分钟。
对于前期铂类治疗失败的患者,多西他赛推荐剂量为单一用药75mg/m2。
治疗中调整剂量:一般性:多西他赛应用于中性粒细胞计数≥1500/mm3的患者。
多西他赛治疗期间,如果患者发生发热性中性粒细胞减少且中性粒细胞数目持续一周以上<500/mm3,出现重度或蓄积性皮肤反应或重度外周神经症状,多西他赛的剂量应由100mg/m2减至75mg/m2,及/或由75mg/m2减至60mg/m2。
若患者在60mg/m2剂量时仍然出现以上症状,应停止治疗。
乳腺癌辅助化疗在关键的临床研究中,接受乳腺癌辅助化疗的患者,出现并发性中性粒细胞减少(包括中性粒细胞减少发生时间延长,发热性中性粒细胞减少,或感染),在所有以后的用药周期中,推荐预防使用G-CSF(如:第4天至第11天)。
若患者持续出现以上反应,应坚持使用G-CSF,并将多西他赛剂量减少至60mg/m2。
然而,临床发生中性粒细胞减少时间较早。
因此应权衡患者中性粒细胞减少的危险及当前使用的推荐剂量而使用G-CSF。
如果未使用G-CSF,多西他赛剂量应由75减至60mg/ m2,发生3级或4级口腔炎的患者应将剂量减至60mg/m2。
联合顺铂治疗对于起始剂量为多西他赛75mg/m2联合顺铂的患者,且前期疗程中曾出现血小板最低值<25000/mm3 , 或曾出现发热性中性粒细胞减少,或曾出现严重的非血液学毒性,下一疗程的多西他赛剂量应减为65mg/m2。
顺铂剂量调整,见其产品介绍。
对于曲妥珠单抗剂量调整,见其产品说明书。
特殊人群:肝功能有损害的患者:根据100mg/m2多西他赛单一用药的药代动力学数据,ALT 和/或AST超过正常值上限1.5 倍同时碱性磷酸酶超过正常值上限2.5倍的患者,多西他赛的推荐剂量为75mg/m2(见《注意事项》及《药代动力学》)。
对于血清胆红素超过正常值上限和/或ALT及AST超过正常值上限3.5倍并伴有碱性磷酸酶超过正常值上限6倍的患者,除非有严格的使用指征,否则不应使用,也无减量使用建议。
无肝功能有损害患者接受泰索帝联合治疗的数据。
【不良反应】从以下单一用药及联合用药的患者中,收集了与多西他赛很可能或可能相关的不良反应:. 1312名患者接受100mg/m2以及121名患者接受75mg/m2多西他赛单药治疗。
. 258名患者接受75mg/m2多西他赛联合阿霉素50mg/m2治疗。
. 406名患者接受75mg/m2多西他赛联合顺铂75mg/m2治疗。
. 92名患者接受多西他赛联合曲妥珠单抗治疗。
. 744名患者接受多西他赛与阿霉素及环磷酰胺联合治疗(与临床重要的治疗相关的不良反应将描述如下)。
根据NCI通用毒性标准(3级=G3,3-4级=G3/4;4级=G4)及COSTART术语来描述反应。
频度定义为:非常常见(>1/10),常见(>1/100,<1/10);不常见(>1/1000,<1/100);少见(>1/10000,<1/1000);罕见(<1/10000)。
在每个频度组按严重程度由高到低的顺序列出不良反应。
多西他赛单药治疗最常见报告的不良反应为:中性粒细胞减少[可逆转且不蓄积(见《用法用量》及《注意事项》);减少至最低点的中位时间为7天,发生重度中性粒细胞减少(<500/mm3) 持续的中位时间为7天],贫血、脱发、恶心、呕吐、口腔炎、腹泻和虚弱。
当多西他赛与其它化疗药物联合使用时可增加多西他赛不良事件的严重程度。
在联合曲妥珠单抗治疗中,列出≥10%的不良事件(所有级别)报告。
在曲妥珠单抗联合组对比多西他赛单药组,SAE发生率(40%比30%)及4级AE(34%比23%)的发生率增高。
泰索帝常见不良反应如下:免疫系统异常过敏反应大多发生在多西他赛开始输注的最初几分钟内,通常是轻度至中度的。
最常报告的症状是伴或不伴有搔痒的红斑及皮疹,胸闷,背痛,呼吸困难及药物性发热或寒颤。
重度反应包括, 低血压和/或支气管痉挛或全身皮疹/红斑,停止输注并进行对症治疗后即可恢复(见《注意事项》)。
神经系统异常当出现重度外周神经毒性症状时,应减少多西他赛的剂量(见《用法用量》及《注意事项》)。
轻至中度感觉神经症状包括感觉异常,感觉障碍或疼痛包括烧灼痛。
运动神经事件主要表现为虚弱。
皮肤及皮下组织异常观察到通常是轻至中度可逆转的皮肤反应,常表现为皮疹,包括主要见于手、足(包括严重的手-足综合征),或发生在臂部,脸部及胸部的局部皮疹,常伴有搔痒。
皮疹多发生于输注多西他赛后一周内。
较少见的重度症状如:极少导致干扰或中断多西他赛治疗的皮疹继而脱皮的报导(见《用法用量》及《注意事项》)。
重度的指甲病变,以色素沉着或色素减退为特点,有时发生疼痛和指甲脱落。
在有些病例中,可能是多种因素造成了以上这些结果,例如:患者伴随的感染,伴随的其他药物以及潜在的疾病。
全身及注射部位异常注射部位一般为轻度反应,包括色素沉着,炎症,皮肤发红或发干,静脉炎或渗出及肿胀。
体液潴留包括如外周水肿,也有少数报道发生胸膜腔积液,心包积液,腹水及体重增加。
外周水肿通常开始于下肢并可能发展至全身伴体重增加3kg或以上。
体液潴留的发生率及程度是可蓄积的(见《注意事项》)。
多西他赛100mg/m2单一用药:血液及淋巴系统异常少见:出血事件合并G3/4血小板减少症。
神经系统异常数据表明多西他赛100mg/m2单一用药后,35.3%具有神经毒反应患者是可逆转的。
在3个月之内自行恢复。
心脏异常不常见:心衰(0.5%)。
胃肠道不适不常见:食道炎(1%,重度0.4%)。
皮肤及皮下组织异常非常少见:一例脱发,在研究结束时未逆转。
73%皮肤反应在21天之内逆转。
全身及注射部位异常至治疗中断的中位累积剂量为超过1,000mg/m2 ,至体液潴留恢复的中位时间为16.4周(范围0-42周)。
发生中度及重度体液潴留的起始时间,预防用药患者(中位累积剂量:818.9mg/m2)比未预防用药患者(中位累积剂量:489.7mg/m2)延迟;然而,有报导在某些患者中,在治疗早期发生体液潴留。
肝脏系统在接受多西他赛单药(100 mg/m²)治疗的患者中,观察到有低于5%的患者出现了血清转氨酶-AST, ALT, 胆红素和碱性磷酸酶水平的升高,并超过正常值上限的2.5倍。
多西他赛75mg/m2单一用药:多西他赛75mg/m2联合阿霉素:总之,接受多西他赛单药治疗的患者与接受多西他赛联合阿霉素治疗的患者相比,发生的不良反应是相似的。
多西他赛75mg/m2联合顺铂:临床上重要的治疗相关性不良事件显示如下。
下面这张表中的安全数据,来自于在一项随机,开放,3种方案对照的临床试验。
在该临床试验中,807例不能切除的IIIB或者IV 期非小细胞肺癌患者,接受了多西他赛的联合治疗,这些患者以前没有接受过化疗。
采用美国的国立癌症研究所制订的常见毒性标准,对这些不良反应进行了描述。
除血液系统毒性或者另行注明以外,这些不良反应被认为可能或很可能与治疗有关。